Minocycline and Aspirin in the Treatment of Bipolar Depression (Minocycline)
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|ClinicalTrials.gov Identifier: NCT01429272|
Recruitment Status : Completed
First Posted : September 7, 2011
Results First Posted : November 8, 2017
Last Update Posted : January 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Depression||Drug: Minocycline Drug: Aspirin Drug: placebo||Phase 3|
New medication classes are needed to improve treatment effectiveness in the depressed phase of bipolar disorder (BD). Extant evidence suggests that BD is not only characterized by reduced monoaminergic signaling, but also by neural changes such as dendritic remodeling, demyelination, and glial and neuronal cell loss. These changes have been hypothesized to result from chronic inflammation, based partly on convergent evidence that proinflammatory cytokines are elevated in depressed patients with BD. The principal aims of the proposed research is to evaluate the antidepressant efficacy in bipolar depression of minocycline, a drug with neuroprotective and immune-modulating properties, and of aspirin, at doses expected to selectively inhibit cyclooxygenase 1 (COX-1), within the context of a randomized, double-blind, placebo-controlled, parallel-group clinical trial following a 2 x 2 design.
Specific Aims Specific Aim 1: To evaluate the efficacy of augmentation therapy with minocycline and/or aspirin for bipolar depression.
The investigators will test the hypothesis that compared with placebo, participants receiving minocycline and/ or aspirin will show a greater treatment response rate (defined as a >50% increase on the MADRS for the final two consecutive visits).
Specific Aim 2: To investigate the relationship between the response to minocycline, aspirin and markers of inflammation (serum concentrations of IL-6 and CRP).
The investigators will test the hypotheses that: a) minocycline treatment will reduce inflammation to a greater extent than placebo; b) during minocycline treatment the change in inflammatory cytokine expression will correlate with the change in depression ratings; c) the baseline elevation of inflammatory markers will predict greater antidepressant response to minocycline.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Minocycline and Aspirin in the Treatment of Bipolar Depression|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||September 2015|
Placebo Comparator: Placebo & Placebo
Placebo for minocycline & placebo for aspirin
placebo for minocycline and/or aspirin
Active Comparator: minocycline & aspirin
Minocycline 100mg PO BID for 6 weeks & Aspirin 81 mg PO BID for 6 weeks
100 mg po bid for 6 weeksDrug: Aspirin
81 mg po bid for 6 weeks
- Treatment Response [ Time Frame: Six weeks ]Response to treatment defined as a >50% decrease in Montgomery-Asberg Depression Rating Scale scores for the final two consecutive visits.
- Remission Rate [ Time Frame: Six weeks ]Remission defined as a score of <11 on Montgomery-Asberg Depression Rating Scale scores for the final two consecutive visits.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429272
|United States, Kansas|
|University of Kansas Medical Center Research Institute|
|Wichita, Kansas, United States, 67207|
|United States, Oklahoma|
|University of Oklahoma Department of Psychiatry|
|Tulsa, Oklahoma, United States, 74135|
|Laureate Institute for Brain Research|
|Tulsa, Oklahoma, United States, 74136-3326|
|Principal Investigator:||Sheldon Preskorn, MD||Laureate Institute for Brain Research, Inc.|